Fifth Circuit Court of Appeals disagrees with Reglan generic drug manufacturer on preemption issue
The U.S. Supreme Court, in Wyeth v. Levine, ruled that the FDA regulations governing pharmaceuticals does not preempt a state-law failure-to-warn claim against the manufacturer of a name brand drug. However, the generic manufacturer of Reglan, Actavis, argued that the Food and Drug Administration (FDA) requires the generic drug manufacturer to use the same drug label as the name brand drug manufacturer. Reglan, a drug intended to treat gastroesophageal reflux, has been associated with tardive dyskinesia, an incurable neurological movement disorder. Actavis produced and sold a generic form of Reglan known as Metoclopramide Tablets.
The arguments by Actavis were spurious at best. The fact is the FDA regulations allow a name brand drug manufacturer to change a label if important safety information needs to be communicated. I've never heard of the FDA later stating warning doctors and consumers about adverse effects of a drug is mislabeling a product. Rather, the federal regulations allow changes to the label without prior FDA approval if the labeling "adds or strengthens a contraindication, warning, precaution, or adverse reaction." In reality, what you usually find, as I found in previous lawsuits against drug manufacturers, is the drug company is doing everything in its power to keep the warning as watered down as possible. Why? Because the bad effects of the drug means less sales.
Further, drug manufacturers know that the federal regulations regarding labeling for safety issues are the minimum standard. At the deposition of an American Home Products, now Wyeth, employee charged with supervising labeling changes, he admitted to me that the FDA labeling regulations are minimum standards that can be exceeded by the drug manufacturer as well as admitting that a labeling change seeking to add or strengthen a warning could be made by a manufacturer without prior FDA approval. Only their executives and lawyers seem to think otherwise.
So how did the Fifth Circuit rule in this case? Last week in Demahy v. Actavis, Inc., the Court held the FDA regulations do not prohibit a generic manufacturer from changing the labeling for safety related issues. In fact, the FDA regulations only require that the initial labeling for the generic drug be the same as the name brand drug. The regulations are silent as to whether further changes are prohibited. The Court found the FDA regulations make clear that "the manufacturer bears responsibility for the content of its label at all times. It is charged both with crafting an adequate label and with ensuring that its warnings remain adequate as long as the drug is on the market." The Court further held that, "as for maintaining an adequate label, the regulatory framework makes plain that manufacturers-name brand and generic alike-must act to warn customers when they learn that they may be marketing an unsafe drug."
This case is another example of the Bush Administrations' attempts to have federal law preempt state product liability law fail. Thankfully, in Wyeth v. Levine, the U. S. Supreme Court stopped the swing of the pendulum towards preemption of state product liability laws. Name brand and generic drug manufacturers will have to face state court juries when they fail to warn doctors and consumers of safety information and consumers are later harmed by their failure to warn.
The Kisselburgh Law Firm is a Mississippi injury law firm that handles all types of cases involving serious injury or death including defective prescription drugs, car accidents, tractor-trailer accidents, motorcycle accidents, drunk driving accidents, and injuries from defective products. If you have questions, call us at 601.936.4040 or contact us online.
